Description

OTC use at home Marijuana drug test strips/dipcard

One Step Marijuana Test Device (Urine) is a rapid chromatographic immunoassay for the detection of 11-nor-Δ -THC-9 COOH (THC metabolite) in human urine at a cut-off concentration of 20ng/ml or 50 ng/mL.

WHAT IS RAPID THC TEST DIPCARD?

Rapid THC Test Dipcard is a qualitative test for the detection of Marijuana and drug metabolites in human urine. The test provide only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

WHAT IS THE CUT-OFF VALUE AND APPROXIMATE DETECTION TIME?

Drug(Identifier)	Cut-off level	Minimum detection time	Maximum detection time
Marijuana (THC)	50 ng/mL	2 hours	Up to 5+ days
Marijuana (THC)	20 ng/mL	2 hours	Up to 5+ days

Product Name	Single Panel Marijuana drug test kits
Brand Name	CIBIO® or OEM
Format	Strip/Dipcard
Methodology	Colloidal Gold
Kit Contents	1. Test Strip
	2. Desiccant
	3. Instruction for use
Application	For over-the-counter (OTC) use, In vitro diagnostic (IVD), at home drug testing
Assay Type	Qualitative Detection
Specimen	Urine only
Specification	Strip:  3.0 mm; 3.5 mm; 4.0 mm Dipcard: 4.0mm
Certificates	ISO 13485, FDA 510K, Clia Waived, CE
Accuracy	Over 99%
Storage Temperature	4-30 degree centigrade
Shelf Life	3 years ( 36 months )
Delivery time	15-30 days
OEM Services	Pouch, Box, Insert, private label
Loading Port	Guangzhou or Shenzhen

HOW TO DO THE TEST? (Dipcard Format)

Test must be at room temperature 59-86ºF (15-30ºC)
1. Open the sealed pouch by tearing along the notch. Remove the test dipcard from the pouch.
2. Hold the one side of the dipcard with one hand. Use the other hand to pull out the cap and expose the absorbent end.
3. Immerse the absorbent end into the urine sample for about 10 seconds. Make sure that the urine level is not above the line printed on the front of the device.
4. Lay the dipcard flat on a clean, dry, non-absorbent surface.
5. Read the results at 5 minutes. The drug test results remain stable for up to thirty minutes. See the illustration.

HOW TO DO THE TEST? (Strip Format)

Test must be at room temperature 59-86ºF (15-30ºC)
1. Open the sealed pouch by tearing along the notch. Remove the test Strip from the pouch.
2. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 10 seconds.
IMPORTANT：Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.
3. Lay the test strip on a clean, dry, non-absorbent surface.
4. Read the results at 5 minutes. The drug test results remain stable for up to thirty minutes. See the illustration.

READING THE RESULTS

Preliminary positive (+)

A rose-pink band is visible in the control region, but no

colored band appears in the test region. This indicates a preliminary positive result for this specific drug. Preliminary positive results must be sent to a lab for a more reliable test.

Negative (-)

A rose-pink band is visible in the control region and the test region. This indicates that the drug is not present in the sample or is at a level that cannot be detected by this test.

Invalid

If a color band is not visible in the control region, or a color band is only visible in the test region, the test is invalid. You should repeat the test with a new test Strip. If the test still shows an invalid result, please contact us at 1-864-538-8007. When calling, be sure to provide the lot number for the test.

Note: There is no meaning to the colored line intensity or width. Any visible line is considered to be a line.

CERTIFICATION